GERD is caused by abnormal regurgitation of acid fluids from the stomach into the esophagus. The stomach generates strong acids to aid digestion. The esophagus is normally protected from these acids by a one-way valve mechanism at its junction with the stomach. This one-way valve is called the lower esophageal sphincter (LES). In patients with GERD, the LES frequently malfunctions because it is either too weak or too short. The short or weak LES cannot retain the contents of the stomach as it fills up and pressure inside rises.
When the LES fails, acid flows backwards, i.e. refluxes, up into the esophagus which is not designed to handle it. The result is an acid burn, commonly called “heartburn”, or “acid indigestion”. Heartburn feels like a burning or pressure pain behind the breastbone, which may feel very much like a heart attack. When the acid is in the esophagus, and one belches, it may regurgitate up into the back of the throat, tasting sour or bitter, and causing a burning sensation. If this occurs at night, one may wake-up with either a hot, fiery feeling in the back of the throat, or even coughing and gasping resulting from acid entering the breathing tubes. This last phenomenon is called Reflux Nocturnal Aspiration and can be quite serious in itself.
Reflux Nocturnal Aspiration can be dangerous, because it introduces acid and bacteria into the airway and lungs. This can cause recurrent bronchitis, pneumonia, lung abscess, or chronic scarring of the lung. It can also lead to asthma attacks in those with an asthmatic tendency.
When acid reflux and its symptoms occur daily or up to three or four times weekly, the esophagus cannot withstand the damaging effects of the acid bath and becomes inflamed, especially at its lower part. Swallowing can frequently be painful, and food may stick in the chest. This is called reflux esophagitis, meaning inflammation of the esophagus due to acid reflux. Persistent esophagitis can cause erosions and ulcers and lead to scarring and narrowing and also irreversible injury to the esophagus.
In some patients, as the esophageal lining becomes increasingly damaged, the body may attempt to try to protect it by changing the lining material to a more resistant type, such as found in the intestine. This change, called Barrett's Esophageal Metaplasia, or Barrett's Esophagus, does not make the symptoms disappear but actually produces a new problem. Metaplastic changes increase the risk of a cancer forming in the new and abnormal lining. Adenocarcinoma of the Gastresophageal Cardia is a highly malignant and fatal type of cancer, the incidence of which is increasing rapidly in America. Some authorities believe that Barrett's esophagus is caused by bile reflux and that the rising incidence of this particular type of cancer is due to the increasing use of medication that suppresses acid production, thus allowing the alkaline bile to reflux unopposed into the esophagus.
The symptoms of acid reflux are uncomfortable, and some sort of relief is usually sought. Some patients chew antacid tablets, sleep on several pillows, or even sleep upright in a recliner. Those with frequent symptoms are treated with drugs that interfere with the formation of acid in the stomach such as Tagamet®, Zantac®, Pepcid®, and Prilosec®. These medications work well in relieving symptoms, till the next dose is due, but they have to be taken daily, often for life, and the cost is substantial (around $1,300 per patient per year).
Moreover, these medications relieve the symptoms, but do not correct the underlying problem.
Currently, the only way to restore the valve function is to operate under a general anesthetic. In the past, the operation was a complex undertaking, entailing a large abdominal or thoracic incision, a lengthy stay in hospital, and a prolonged absence from work. Today, the operation can be done laparoscopically. This shortens the hospital stay, from about ten days to two or three days, but is still carried on under a general anesthetic, and is associated with a significant complication rate. Therefore gastroenterologists are often reluctant to refer patients to surgeons for anti-reflux surgery and many patients who should be operated upon are not.
It is estimated that in the USA alone, 65 million people suffer from heartburn and GERD symptoms are currently the most common complaint of patients who consult with gastroenterologists. According to the New England Journal of Medicine, nearly 40% of adult Americans suffer from heartburn; of those who seek treatment for symptoms of reflux esophagitis, 10 to 20% have serious complications (about 4-8% of the total adult population).
Surgical procedures are usually effective in controlling severe gastroesophageal reflux disease. Surgical procedures are designed to correct gastroesophageal reflux by creating a new functional lower esophageal sphincter and to repair a hiatal hernia when present. The most popular approach is the Nissen fundoplication or a modification of this technique [The Esophagus, 3rd Ed., Donald O. Castell, Ed., pp. 515-517]. It involves mobilization and wrapping of the fundus of the stomach around the lower esophagus. As pressure increases in the stomach it compresses the lower esophagus, preventing reflux. The procedure is performed after first placing a large dilator in the esophagus in order to prevent making the wrap too tight. Fundoplication performed by either a traditional open or laparoscopic technique should be identical, except that access to the esophagus by laparoscopy is through a series of four or five punctures in the abdominal wall, rather than by an upper abdominal incision. The advantages of the open technique include the ability to see structures in three dimensions and to palpate them. Laparoscopy provides a clear magnified view of the area of surgery and is associated with less pain and more rapid recovery postoperatively.
The procedure is illustrated in FIG. 1. The length of the suture “S” is 2.5 to 3.0 cm, and 2 to 5 sutures are typically required. Because wrapping the stomach “ST” 360 degrees around the esophagus “E”, as shown in FIG. 1, is associated with inability or difficulty in belching and vomiting, partial fundoplications have been devised. These include the Toupet posterior partial fundoplication (270 degrees) [Ibid, pp. 517-518] illustrated in FIG. 2, in which “E” is the esophagus, “AW” is the anterior wall of wrap sutured to the esophagus, and “GJ” is the gastroesophageal junction, and the Thal anterior fundoplication (180 degrees), illustrated in FIG. 3, where “F” indicates the fundus being plicated.
All these procedures have an excellent track record in terms of safety, and ability to control both biliary and acid reflux. However, they can only be carried out laparoscopically or via a laparotomy (abdominal incision) or a thoracotomy (opening the chest). Either way, general anesthesia is required. Because of this disadvantage, the art has attempted do devise minimally invasive methods and apparatus that can be used to carry out fundoplication procedures. U.S. Pat. No. 5,403,326 describes a fundoplication method of the stomach to the esophagus that requires the introduction of an esophageal manipulator and a stapler into the stomach lumen, and the stapling the intussusception esophagus to the stomach. U.S. Pat. No. 5,558,665, and its related patent U.S. Pat. No. 5,787,897, disclose a variform intraluminal member that can be used to manipulate the fundus to a position where it can be fastened by other devices, and a method for carrying out such surgery. U.S. Pat. No. 5,571,116, and its related U.S. Pat. Nos. 5,676,674 and 5,897,562 describe a multi-stapler device, and associated staplers, for carrying out an automatic approximation of the lower esophagus and fundus of the stomach and for invaginating the gastroesophageal junction into the stomach, thereby involuting the surrounding fundic wall.
WO 00/53102 describes a method and apparatus for minimally-invasive fundoplication which requires using a gripping head to grip the fundus and to move it toward the esophagus. The device of this reference has the severe drawback of being unable to position the stapling head precisely, and therefore any attempt to carry out a fundoplication may result in dangerous damage being inflicted on the patient. Furthermore, it entails an undesirable perforation of the fundus by the gripping head.
Not with standing the great efforts made in the art to overcome the need for major surgery in the treatment of GERD, none of the abovementioned devices and methods have gained any actual popularity, and they are currently not in use. The reasons for this fact are many, and include the difficulty in controlling the operation of the device, the inherent disadvantages of the types of fundoplications that can be achieved by them, the ongoing need for additional invasive operations, particularly the laparoscopic introduction of devices, etc. It is therefore clear that there is a need in the art for a fundoplication method that can be effectively used for the treatment of GERD, and which is free from the above disadvantages of prior art methods and devices.
An endoscopic apparatus and method of using it, for the treatment of GERD, which overcomes many of the aforementioned drawbacks of the prior art has been described in published International Patent Applications WO01/67964, WO/02/39909, WO02/24058, WO02/068988, WO2005/002210, WO2005/115221, WO2005/115255, WO2005/120329, and WO2006/033109 by the same applicant hereof, the descriptions of which, including publications referenced therein, are incorporated herein by reference.
It is therefore a purpose of the present invention to provide a transgastric method for the endoscopic partial fundoplication for the treatment of GERD that is simpler, safer, quicker and more effective than the methods of the prior art.
It is another purpose of the present invention to provide an endoscopic system for carrying out a transgastric method for the endoscopic partial fundoplication for the treatment of GERD.
Further purposes and advantages of this invention will appear as the description proceeds.